Fecal management applicator and assembly

ABSTRACT

A fecal management applicator, a fecal management assembly, and a fecal management method are described herein. A fecal management applicator may include a handle portion, and a head portion extending from the handle portion. The head portion may include an inner head wall portion that extends axially from the handle portion and an outer head wall portion that extends radially outwardly from the inner head wall portion and curves over the inner head wall portion. The fecal management applicator may define a channel that extends continuously through the handle portion and the head portion along an entire axial length of the fecal management applicator.

TECHNICAL FIELD

This disclosure relates generally to medical devices and, moreparticularly, to a fecal management applicator and a fecal managementassembly.

BACKGROUND

Many challenges exist surrounding the care of patients that areincontinent, bedridden, or otherwise unable to care for themselves.Management of waste produced by such patients poses unique challenges.For example, the waste of a bedridden patient must be kept away from thepatient for reasons of sanitation and the reduce the occurrence of soresand infection. Many fecal management systems include a collection bag.When the collection bag becomes full, the entire fecal management systemmust be removed from the patient. This may cause pain, discomfort,injury to the patient and can be inconvenient for the caregiver.

Described herein are fecal management devices and methods that seek tominimize, if not overcome, the disadvantages of the above-describedfecal management systems.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a representational view illustrating various components of afecal management assembly.

FIG. 2 is a top perspective view of a fecal management applicator.

FIG. 3 is a bottom perspective view of the fecal management applicator.

FIG. 4 is a front elevation view of the fecal management applicator.

FIG. 5 is a side elevation view of the fecal management applicator.

FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 5.

FIG. 7 is a cross-sectional view taken along line 7-7 of FIG.4.

FIG. 8 is a top plan view of the fecal management applicator.

FIG. 9 is a bottom plan view of the fecal management applicator.

FIG. 10 is a perspective view of a portion of the fecal managementassembly FIG. 1 in an assembled configuration.

FIG. 11 is a first exploded perspective view of another fecal managementapplicator.

FIG. 12 is a second exploded perspective view of the fecal managementapplicator of FIG. 11.

FIG. 13 is a first perspective view of another fecal managementapplicator.

FIG. 14 is a second perspective view of the fecal management applicatorof FIG. 13.

FIG. 15 is a first perspective view of another fecal managementapplicator in an open configuration.

FIG. 16 is a second perspective view of the fecal management applicatorof FIG. 15 in the open configuration.

FIG. 17 is a first perspective view of the fecal management applicatorof FIG. 15 in a closed configuration.

FIG. 18 is a second perspective view of the fecal management applicatorof FIG. 15 in the closed configuration.

DETAILED DESCRIPTION

Embodiments of the present disclosure are described herein. It is to beunderstood, however, that the disclosed embodiments are merely examplesand other embodiments may take various and alternative forms. Thefigures are not necessarily to scale; some features could be exaggeratedor minimized to show details of particular components. Therefore,specific structural and functional details disclosed herein are not tobe interpreted as limiting, but merely as a representative basis forteaching one skilled in the art to variously employ the presentinvention. As those of ordinary skill in the art will understand,various features illustrated and described with reference to any one ofthe figures may be combined with features illustrated in one or moreother figures to produce embodiments that are not explicitly illustratedor described. The combinations of features illustrated providerepresentative embodiments for typical applications. Variouscombinations and modifications of the features consistent with theteachings of this disclosure, however, could be desired for particularapplications or implementations.

Referring to FIG. 1, a fecal management assembly 10 includes a fecalmanagement applicator 12 and a sheath 14 that may extend through thefecal management applicator 12. More particularly, the sheath 14 mayextend through a channel of the fecal management applicator 12, asdiscussed in greater detail elsewhere herein.

The sheath 14 includes a first end 16 (proximal to the patient) and asecond end 18 (distal from the patient). The sheath 14 may include anelongated portion 20, which may be a tubular elongated portion. Thesheath 14 may further include a tapering portion 22 that extends fromthe elongated portion 20 to the first end 16. The tapering portion 22may taper from a generally circular cross-section (e.g., adjacent theelongated portion 20) to a generally elliptical cross-section (e.g.,adjacent the first end 16).

An adhesive substrate 30 may be affixed to the first end 16 of thesheath 14. The adhesive substrate 30 may be configured for connection tothe buttocks of a patient. The adhesive substrate 30 may include acentral portion 32 that defines a central aperture 34. The centralaperture 34 may be an elliptical aperture that may be secured to thefirst end 16 of the sheath 14. The adhesive substrate 30 may furtherinclude opposing wing sections 36 that extend from the central portion32. The adhesive substrate 30 may include, for example, a hydrocolloidadhesive disposed on a patient-interfacing side of the adhesivesubstrate 30. The hydrocolloid adhesive may be applied to sensitiveareas of the patient's buttocks. In some approaches, the adhesivesubstrate 30 remains adhered to a patient for a prolonged period of time(e.g., one week or longer).

A backing layer 40 may be applied to the adhesive substrate 30. Thebacking layer 40 may be a single backing layer or, as shown, may includea plurality of discrete backing layer components. The backing layer 40may be configured to protect the adhesive substrate 30 and prevent theadhesive substrate 30 from adhering prematurely or to unwanted surfaces.The backing layer 40 may comprise a material that can facilitate removalof the backing layer 40 from the adhesive substrate 30 to expose atleast a portion of the adhesive substrate 30. The material may be, forexample, a coated paper such as wax paper. Accordingly, the backinglayer 40 may be removed from the adhesive substrate 30 prior to and/orduring application of the adhesive substrate 30.

The fecal management assembly 10 may include a sheath port 50. Thesheath port 50 may be provided, for example, at the second end 18 of thesheath 14. The sheath port 50 may be a discrete component separate fromthe sheath 14, and may be connected to the sheath 14, for example, via aclip, snap fit, heat seal, etc. Alternatively, the sheath port 50 may beintegrally formed with the sheath 14 (e.g., as a single molded orextruded piece).

In some aspects, the fecal management assembly 10 may include a sheathport cap 52. The sheath port cap 52 may be tethered to the sheath port50 (for example, at a sheath port cap connector 54), or may be tethereddirectly to the sheath 14. The sheath port cap 52 may be configured tomate with a sheath port opening 56 of the sheath port 50 to preventunwanted egress of fecal matter from the sheath 14 when a collection bagis removed. The sheath port cap 52 can mate with the sheath port 50 inany suitable manner. For example, the geometry of the sheath port cap 52can be such that the sheath port cap 52 is retained within the sheathport opening 56 of the sheath port 50 due to a tight tolerance. In thisexample, the sheath port cap 52 can include a portion that is sizedslightly smaller than the sheath port opening 56 and/or may includepliable material that allows insertion of the sheath port cap 52 in thesheath port opening 56. Alternatively, or additionally, the sheath portcap 52 may include a mating mechanism that is complementary to the ofthe sheath port 50.

The fecal management assembly 10 may include a collection bag assembly60. The collection bag assembly 60 may include a collection bag formedof a first section 62 and a second section 64. The first section 62 andthe second section 64 may comprise fluid-impermeable plastic and may beaffixed to one another (e.g., via heat sealing). In another approach,the collection bag is a single-component collection bag.

The collection bag assembly 60 may further include an anti-reflux device66 that may inhibit unwanted egress of fecal matter from the collectionbag assembly 60, for example, if the collection bag assembly 60 isrotated. The collection bag assembly 60 may further include a filterport 70 that allows gas to escape from the collection bag assembly 60 toprevent inflation of the collection bag assembly 60. The filter port 70may include a filtering device 72 to diminish odor emanating from thecollection bag assembly 60 via the filter port 70. A hanger 80 may beconfigured to allow the collection bag assembly 60 to be hung, forexample, from a bed frame or a flat metal surface as is sometimes foundin caregiver settings.

The collection bag assembly 60 may further include a collection bag port90. The collection bag port 90 may be affixed to a collection bag so asto allow fecal matter to flow into the collection bag via a collectionbag port opening 92.

The collection bag port 90 may be configured to mate with the sheathport 50, and vice versa. The collection bag port 90 can mate with thesheath port 50 via a connection mechanism (e.g., ball and detent, postand recess, bayonet connector, etc.) that may permit the collection bagassembly 60 to be removable secured to the sheath 14. According to oneaspect, the connection mechanism is a quick connect mechanism thatallows the collection bag port 90 to be quickly and easily removed fromthe sheath port 50. In this manner, the collection bag port 90 allows acollection bag assembly 60 to be quickly and easily removed from thesheath 14.

Because the collection bag assembly 60 may be removed from the sheath14, portions of the fecal management assembly 10 can continue to be usedafter the collection bag assembly 60 is removed (e.g., while beingreplaced by another collection bag). As such, the sheath 14 can remainsecured to the patient via the adhesive substrate 30 during replacementof the collection bag assembly 60. This may decrease discomfort andincidence of injury for the patient, as may occur during removal of theadhesive substrate 30 from the patient.

Referring to FIGS. 2 and 3, the fecal management applicator 12, alsoreferred to herein as applicator 12, includes a handle portion 100 and ahead portion 102 that extends from the handle portion. At least aportion of the handle portion 100 may be in the form of an elongatedtube that extends along a longitudinal axis 110, which may extendparallel to the Z axis of FIGS. 2 and 3. At least a portion of anexterior surface of the handle portion 100 may include an ergonomichand-gripping surface. The ergonomic hand-gripping surface may be agenerally smooth tubular surface, or may include other features, such asridges, protrusions, depressions, contours, flutes, etc., that mayassist a user in gripping and/or manipulating the handle portion 100.

The head portion 102 may be a generally ellipsoidal head portion havinga major axis 112 that extends parallel to the Y axis, and a minor axis114 that extends parallel to the X axis.

The applicator 12 defines a channel 120. More particularly, the handleportion 100 and the head portion 102 cooperate to define a channel 120that extends continuously through the handle portion 100 and the headportion 102 (e.g., along the Z axis). The channel 120 may extend, forexample, along an entire axial length of the applicator 12. 2. At leasta portion of the channel may be a generally cylindrical channel.

The applicator 12 may include an elongated slit 130. The elongated slit130 may be provided at a side portion of the applicator 12; for example,at side 132. The elongated slit 130 may extend through an entirethickness of the side 132 (e.g., along the Y axis direction). In thisway, the elongated slit 130 may extend from the channel 120 outwardly toan external surface of the side 132. Furthermore, the elongated slit 130may extend longitudinally (e.g., along the Z axis direction) along theentire axial length of the applicator 12. As such, the elongated slit130 may extend through the handle portion 100 and the head portion 102.More particularly, the elongated slit 130 may extend from a bottomsurface 140 of the handle portion 100 to a top surface 142 of the headportion 102.

The elongated slit 130 may extend a greater distance from the channel120 (e.g., along the Y axis direction) in the head portion 102 ascompared to in the handle portion 100. As shown in FIG. 2, the elongatedslit 130 may extend from the channel 120 to a perimeter surface 144 ofthe head portion 102. The perimeter surface 144 may be disposed, forexample, along the major axis 112 of the head portion 102. In oneaspect, the perimeter surface 144 may define a tapered region 146 of theelongated slit 130.

In one aspect, the handle portion 100 may include or define a transverseslot 150. The transverse slot 150 may be provided at a forward-facingwall 152 of the handle portion 100. The forward-facing wall 152 may beangularly offset (e.g., about the longitudinal axis 110) from the side132 of the handle portion 100. The transverse slot 150 may extendthrough an entire thickness of the forward-facing wall 152 (e.g., alongthe X axis direction from the channel 120 to an exterior surface of theforward-facing wall 152).

Referring to FIGS. 4 and 5, the transverse slot 150 may extend from theelongated slit 130, and may extend in a plane defined by the X and Yaxes. In one aspect, the transverse slot includes a tapered region 154that extends from the elongated slit 130, and a constant-width, orsubstantially constant-width, region 156 that extends from the taperedregion 154.

The head portion 102 may include an outer surface 160. The outer surface160 may include the perimeter surface 144, previously discussed. Theouter surface 160 may be a generally ellipsoidal outer surface. As such,the outer surface 160 may have a first slope in a direction of the majoraxis 112 that is more gradual than a second slope in a direction of theminor axis 114. A lower edge 162 of the head portion 102 may generallydefine a hyperbolic paraboloid.

Referring to FIGS. 6 and 7, the head portion 102 may include an innerhead wall portion 170 and an outer head wall portion 172. The inner headwall portion 170 may extend axially (e.g., in the Z direction) from thehandle portion 100. The outer head wall portion 172 may extend from theinner head wall portion 170. For example, the outer head wall portion172 may extend radially outwardly from the inner head wall portion 170(e.g., generally in the Y direction). The outer head wall portion 172may also curve over the inner head wall portion 170 (e.g., generallyoutwardly in the Y direction and downwardly in the Z direction). Theouter head wall portion 172 may define at least a portion of the outersurface 160 and at least a portion of the lower edge 162.

Referring to FIGS. 6-8, at least a portion of the inner head wallportion 170 may be tapered relative to a central axis 180 of the channel120. More particularly, an inner surface 174 of the inner head wallportion 170 may taper outwardly (e.g., in the Y direction) as the innersurface 174 of the inner head wall portion 170 extends away from thehandle portion 100 (e.g., in the Z direction). In one aspect, the innerhead wall portion 170 tapers outwardly in a first verticalcross-sectional plane, such as the Y-Z plane of FIG. 6, and issubstantially parallel in a second vertical cross-sectional plane thatis transverse to the first vertical cross-sectional plane, such as theX-Z plane of FIG. 7. Furthermore, the inner head wall portion 170 mayhave a generally circular shape at a first axial height 182 along thecentral axis 180, and may have a generally elliptical shape at a secondaxial height 184 that is axially offset from the first axial height.

The head portion 102 may include or define a head slot 190. The headslot 190 may extend through at least one of the inner head wall portion170 and the outer head wall portion 172. The head slot 190 may extendfrom the channel 120 opposite the elongated slit 130 (e.g., generallyparallel to the Y axis). In one aspect, at least a portion of the headslot 190 may have a thickness (e.g., in the X direction) that is greaterthan a thickness of the elongated slit 130. For example, the head slot190 may have a thickness that is approximately (e.g., +/−10%) 1 mmgreater than the thickness of the elongated slit 130.

Referring to FIG. 9, the head portion 102 may include one or more gaps192 between the outer head wall portion 172 and the inner head wallportion 170. In this way, at least a portion of the outer head wallportion 172 may be spaced apart from at least a portion of the innerhead wall portion 170. More particularly, a radially-inward surface ofthe outer head wall portion 172 may be spaced apart from aradially-outward surface of the inner head wall portion 170.

The head portion 102 may include one or more ribs 194 that extend fromthe inner head wall portion 170 to the outer head wall portion 172. Theribs 194 may be reinforcing ribs that provide support for the outer headwall portion 172.

Referring to FIG. 10, a portion 200 of the fecal management assembly 10of FIG. 1 is shown in an assembled configuration. More particularly, thesheath 14 is shown with the adhesive substrate 30 attached thereto(e.g., at the first end 16 of the tapering portion 22 of the sheath 14).The sheath 14 and adhesive substrate 30 are assembled with theapplicator 12.

A method of assembling the portion 200 may include inserting the sheath14 through the elongated slit 130 of the applicator 12 and into thechannel 120. Inserting the sheath 14 may include disposing at least aportion of the tapering portion 22 of the sheath 14 within the headportion 102 of the applicator 12, and disposing at least a portion ofthe elongated portion 20 within the handle portion 100. The method mayinclude placing the adhesive substrate across at least a portion of theouter surface 160 of the head portion 102. The method may furtherinclude placing at least a portion of the sheath 14 (e.g., the elongatedportion 20 of the sheath 14) through the transverse slot 150 of thehandle portion 100. This may allow a user to adjust a tension of thesheath 14 within the channel 120 and/or the tension of the adhesivesubstrate 30 across the outer surface 160.

A method of assembling the fecal management assembly 10 may includeconnecting the sheath 14 to a collection bag assembly (e.g., thecollection bag assembly 60 of FIG. 1). Upon connecting, a collection bagmay be provided in fluidic communication with the second end of thesheath 14.

A method of applying the fecal management assembly 10 may includeapplying the adhesive substrate 30, via the applicator 12, to a patient(e.g., to a patient's buttocks proximate the patient's anus). Applyingthe adhesive substrate 30 to the patient may secure adhesive of theadhesive substrate 30 to the patient. The method may further includemanipulating the handle portion 100 of the applicator 12 to rotateportions of the head portion 102 (and thereby, the adhesive substrate30) toward and away from the patient's skin. Such manipulation mayachieve a fluid-tight (or substantially fluid-tight) seal between theadhesive substrate 30 and the patient's skin.

A method of removing the applicator 12 may include removing a portion ofthe sheath 14 from the transverse slot 150 of the handle portion 100.The method may further include removing the sheath 14 from the channel120 of the applicator 12. Removal of the sheath 14 from the channel 120may include passing the sheath 14 through the elongated slit 130 of theapplicator 12.

As such, the applicator 12 may be provided to assist a user in applyingan adhesive substrate 30 to a patient. Upon application of the adhesivesubstrate 30, the applicator 12 may be removed from the sheath 14, whilethe sheath 14 remains secured to the patient via the adhesive substrate30. The applicator 12 may subsequently be discarded, or may be cleansedor decontaminated (e.g., disinfected or sterilized) for future use.

Referring to FIG. 11, a fecal management applicator, referred to hereinas applicator 250, is shown. The applicator 250 may include a handlebody 252 and a head body 254. The handle body 252 may generallycorrespond to handle portion 100, previously discussed. Similarly, thehead body 254 may generally correspond to head portion 102, previouslydiscussed.

In the approach of FIG. 11, the handle body 252 and the head body 254may be discretely formed bodies. That is, the handle body 252 and thehead body 254 are formed as separate components.

The handle body 252 may be formed at least in part of a material havinga first hardness, and the head body 254 may be formed at least in partof a material having a second hardness that is different than the firsthardness. More particularly, the handle body 252 may have a greaterhardness than the hardness of the head body 254. Each hardness may bemeasured, for example, with a durometer, and may be express on adurometer scale such as the Shore A or Shore D scale.

In one aspect, the handle body 252 may be formed at least in part of afirst material, and the head body 254 may be formed at least in part ofa second material that is different than the first material. In anotheraspect, the handle body 252 and the head body 254 are formed at least inpart of a common material, such that the common material has a firsthardness in the handle body 252 and a second hardness in the head body254 that is different than the first hardness.

The handle body 252 may have a first interface 260, and the head body254 may have a second interface 262 for interfacing the first interface260. The first interface 260 and the second interface 262 may havecomplementary geometries (e.g., complementary protrusions andreceptacles). During assembly, the first interface 260 of the handlebody 252 may be brought into engagement with the second interface 262 ofthe head body 254. The head body 254 may be fixedly secured to thehandle body 252. For example, the head body 254 may be bonded to thehandle body 252 with an adhesive or by a welding process (e.g.,ultrasonic welding).

As such, in the assembled configuration, the applicator 250 may have arelatively rigid handle body 252, and a relatively flexible head body254. The relatively rigid handle body 252 may assist a user inmanipulating the applicator 250, while the relatively flexible head body254 may assist in applying and/or securing an adhesive substrate (e.g.,adhesive substrate 30) to a patient. Also in the assembledconfiguration, the applicator 250 may include one or more features ofthe applicator 12, previously discussed. As such, the applicator 250 inthe assembled configuration may generally correspond to the applicator12.

Referring to FIGS. 13 and 14, a fecal management applicator, referred toherein as applicator 270, is shown. The applicator may include a handleportion 272 and a head portion 274. The applicator 270 may include oneor more features that generally correspond to applicator 12, previouslydiscussed. For example, the handle portion 272 may generally correspondto handle portion 100, and the head portion 274 may generally correspondto head portion 102.

The applicator 270 may include a hinge region 280, and an expandableelongated slit 282 disposed opposite (e.g., diametrically opposite) thehinge region 280. As shown in FIG. 14, the hinge region 280 may extendthrough at least a portion of the handle portion 272. The hinge region280 may also, or may instead, extend through at least a portion of thehead portion 274.

The hinge region 280 may permit slit edges 284 of the expandableelongated slit 282 to expand apart. For example, the slit edges 284 mayrotate about a hinge axis 286, as shown in FIG. 14. In at least oneapproach, the hinge region 280 includes a living hinge. As such, amaterial thickness of one or both of the handle portion 272 and the headportion 274 may be reduced at the hinge region 280. The applicator 270may be configured to bias the expandable elongated slit 282 toward aclosed configuration, and the living hinge may be adapted to permitexpansion of the slit edges 284 of the expandable elongated slit 282. Inat least another approach, a hinge pin is provided at the hinge region280 to permit relative rotation of the slit edges 284 about the hingeaxis 286.

Referring to FIGS. 15-18, a fecal management applicator, referred toherein as applicator 300, is shown. The applicator 300 may include afirst side member 302 and a second side member 304.

The first side member 302 may include a first handle portion 310 and afirst head portion 312. The first head portion 312 may include a firstinner wall portion 314 that extends from the first handle portion 310,and a first outer wall portion 316 that extends radially outwardly fromthe first inner wall portion 314. The first outer wall portion 316 mayalso curve over the first inner wall portion 314. The first side member302 may include a first channel portion 318 that may extend along thefirst handle portion 310 and the first head portion 312 (e.g., along thefirst inner wall portion 314).

The second side member 304 may include a second handle portion 320 and asecond head portion 322. The second head portion 322 may include asecond inner wall portion 324 that extends from the second handleportion 320, and a second outer wall portion 326 that extends radiallyoutwardly from the second inner wall portion 324. The second outer wallportion 326 may also curve over the second inner wall portion 324. Thesecond side member 304 may include a second channel portion 328 that mayextend along the second handle portion 320 and the second head portion322 (e.g., along the second inner wall portion 324).

The first side member 302 may include a first connection interface 330,and the second side member 304 may include a second connection interface332. In one aspect, one or both of the first connection interface 330and the second connection interface 332 may include an interference-fitinterface, press-fit interface, friction-fit interface, or the like. Assuch, the first connection interface 330 and the second connectioninterface 332 may have complementary geometries (e.g., complementaryridges, protrusions, receptacles, etc.). The first connection interface330 may be configured to engage the second connection interface 332 (orvice versa) to secure the first side member 302 to the second sidemember 304.

In an assembled configuration, shown in FIGS. 17 and 18, the first sidemember 302 and the second side member 304 may be disposed in engagementto form the assembled applicator 300. The engagement may be a releasableengagement such that the second side member 304 may be selectivelydisengaged from the first side member 302.

Also in the assembled configuration, the applicator 300 may include oneor more features of the applicator 12, previously discussed. Forexample, the first side member 302 and the second side member 304 maycooperate to define a channel 340 therebetween. More particularly, thefirst channel portion 318 and the second channel portion 328 maycooperate to define the channel 340 therebetween. The channel 340 mayextend continuously through along an entire axial length of theassembled applicator. As such, the applicator 300 in the assembledconfiguration may generally correspond to the applicator 12.

The various components and features discussed with respect to anindividual applicator 12, 250, 270, 300 discussed herein may be usedinterchangeably with the fecal management assembly 10 of FIG. 1 and/orthe portion 200 of the fecal management assembly 10 discussed withrespect to FIG. 10.

Furthermore, the various components and features discussed with respectto an individual applicator 12, 250, 270, 300 discussed herein are notlimited to such applicator. As such, it is expressly contemplated thatvarious components and features of an individual applicator 12, 250,270, 300 may be provided with, or incorporated into, other applicatorsdiscussed herein.

While exemplary embodiments are described above, it is not intended thatthese embodiments describe all possible forms encompassed by the claims.The words used in the specification are words of description rather thanlimitation, and it is understood that various changes may be madewithout departing from the spirit and scope of the disclosure. Aspreviously described, the features of various embodiments may becombined to form further embodiments of the invention that may not beexplicitly described or illustrated. While various embodiments couldhave been described as providing advantages or being preferred overother embodiments or prior art implementations with respect to one ormore desired characteristics, those of ordinary skill in the artrecognize that one or more features or characteristics may becompromised to achieve desired overall system attributes, which dependon the specific application and implementation. These attributes mayinclude, but are not limited to cost, strength, durability, life cyclecost, marketability, appearance, packaging, size, serviceability,weight, manufacturability, ease of assembly, etc. As such, embodimentsdescribed as less desirable than other embodiments or prior artimplementations with respect to one or more characteristics are notoutside the scope of the disclosure and may be desirable for particularapplications.

All methods described herein can be performed in any suitable orderunless otherwise indicated herein or otherwise clearly contradicted bycontext. The use of any and all examples, or language describing anexample (e.g., “such as”) provided herein, is intended to illuminate theinvention and does not pose a limitation on the scope of the invention.Any statement herein as to the nature or benefits of the invention or ofthe preferred embodiments is not intended to be limiting. This inventionincludes all modifications and equivalents of the subject matter recitedherein as permitted by applicable law. Moreover, any combination of theabove-described elements in all possible variations thereof isencompassed by the invention unless otherwise indicated herein orotherwise clearly contradicted by context. The description herein of anyreference or patent, even if identified as “prior,” is not intended toconstitute a concession that such reference or patent is available asprior art against the present invention. No unclaimed language should bedeemed to limit the invention in scope. Any statements or suggestionsherein that certain features constitute a component of the claimedinvention are not intended to be limiting unless reflected in theappended claims. Neither the marking of the patent number on any productnor the identification of the patent number in connection with anyservice should be deemed a representation that all embodiments describedherein are incorporated into such product or service.

What is claimed is:
 1. A fecal management applicator comprising: ahandle portion; and a head portion extending from the handle portion,the head portion including an inner head wall portion that extendsaxially from the handle portion and an outer head wall portion thatextends radially outwardly from the inner head wall portion and curvesover the inner head wall portion, wherein the fecal managementapplicator defines a channel that extends continuously through thehandle portion and the head portion along an entire axial length of thefecal management applicator.
 2. The fecal management applicator of claim1 wherein at least a portion of the channel is a generally cylindricalchannel.
 3. The fecal management applicator of claim 1 wherein at leasta portion of an exterior surface of the handle portion includes anergonomic hand-gripping surface.
 4. The fecal management applicator ofclaim 1 wherein at least a portion of the handle portion is an elongatedtube.
 5. The fecal management applicator of claim 1 wherein at least aportion of the inner head wall portion is tapered relative to a centralaxis of the channel.
 6. The fecal management applicator of claim 1wherein the inner head wall portion tapers outwardly in first verticalcross-sectional plane, and wherein the inner head wall portion issubstantially parallel in a second vertical cross-sectional plane thatis transverse to the first vertical cross-sectional plane.
 7. The fecalmanagement applicator of claim 1 wherein the inner head wall portion hasa generally circular shape at a first axial height, and has a generallyelliptical shape at a second axial height that is axially offset fromthe first axial height.
 8. The fecal management applicator of claim 7wherein the outer head wall portion is generally ellipsoidal.
 9. Thefecal management applicator of claim 8 wherein the generally ellipsoidalouter head wall portion has a first slope in a direction of a major axisthat is more gradual than a second slope in a direction of a minor axis.10. The fecal management applicator of claim 1 wherein the head portiondefines a gap between the outer head wall portion and the inner headwall portion such that at least a portion of the outer head wall portionis spaced apart from at least a portion of the inner head wall portion.11. The fecal management applicator of claim 10 wherein the head portionincludes at least one rib extending within the gap from the inner headwall portion to the outer head wall portion.
 12. The fecal managementapplicator of claim 1 wherein the handle portion is a handle body havinga first material hardness, and wherein the head portion is a head bodyhaving a second material hardness different than the first materialhardness.
 13. The fecal management applicator of claim 1 wherein thefecal management applicator defines an elongated slit that extendsaxially through a side of the fecal management applicator along theentire axial length of the fecal management applicator.
 14. The fecalmanagement applicator of claim 13 wherein the elongated slit extendsfrom the channel to a perimeter surface of the head portion.
 15. Thefecal management applicator of claim 14 wherein the head portion definesa head slot extending through at least one of the inner head wallportion and the outer head wall portion, the head slot extending fromthe channel opposite the elongated slit.
 16. The fecal managementapplicator of claim 13 wherein the handle portion defines a transverseslot extending from the elongated slit.
 17. The fecal managementapplicator of claim 16 wherein the transverse slot includes a taperedslot region that extends from the elongated slit.
 18. The fecalmanagement applicator of claim 13 wherein the fecal managementapplicator includes a hinge region disposed diametrically opposite fromthe elongated slit.
 19. The fecal management applicator of claim 18wherein the hinge region includes a living hinge configured to bias theelongated slit toward a closed configuration, and adapted to permitexpansion of the fecal management applicator at the elongated slit. 20.A fecal management applicator comprising: a first side member; and asecond side member, wherein each of the first and second side membersincludes a handle portion and a head portion extending from the handleportion, each head portion including an inner wall portion that extendsaxially from the handle portion and an outer wall portion that extendsradially outwardly from the inner wall portion and curves over the innerwall portion, wherein each of the first and second side members furtherincludes a connection interface, wherein in an assembled configuration,the first and second side members are releasably secured at theconnection interfaces such that the first and second side members definea channel therebetween that extends continuously through along an entireaxial length of the fecal management applicator.
 21. A fecal managementassembly comprising: a fecal management applicator including a handleportion and a head portion extending from the handle portion, the fecalmanagement applicator defining a channel that extends continuouslythrough the handle portion and the head portion along an entire axiallength of the fecal management applicator; a sheath that extends throughthe channel, the sheath having a first end proximate the head portionand a second end opposite the first end; an adhesive disposed at thefirst end of the sheath; and a collection bag in fluidic communicationwith the second end of the sheath.
 22. A fecal management methodcomprising: providing a fecal management assembly including a fecalmanagement applicator having a handle portion, and a head portionextending from the handle portion, the fecal management applicatordefining a channel that extends continuously through the handle portionand the head portion along an entire axial length of the fecalmanagement applicator, a sheath that extends through the channel, thesheath having a first end proximate the head portion and a second endopposite the first end, an adhesive disposed at the first end of thesheath, and a collection bag in fluidic communication with the secondend of the sheath; securing the adhesive to a patient; and with theadhesive secured to the patient, removing the sheath from the channel.